The treatment of benign neoplasms of the nasal cavity, such as, e.g., inflammatory nasal polyps, granulomas, etc., typically involves surgery, systemic doses of steroids, steroid injections and steroid irrigation. To date, these treatments have been costly and impractical for long term prevention or regrowth of the neoplasm.
Surgery presents risk to the patient and is expensive for both the patient and the healthcare system, particularly regular, repeat surgical procedures common for these disorders. In addition, surgical resection of both benign and malignant neoplasms and therapeutic surgical alteration of the nose and paranasal sinuses often result in removal of anatomic structures such as the nasal turbinates, nasal septum, nasal mucosa, etc. Such ablative and reconstructive surgeries can result in disruption of the natural filtering and humidification provided by these structures resulting in dryness, bleeding, crusting, increased risk of infection and changes in olfaction including hyposmia, dysosmia, parosmia and anosmia.
Current management includes saline irrigation and nasal sprays which frequently do not reach many of the areas of concern in the nasal vestibule and paranasal sinus areas. Such irrigation and nasal sprays can also result in pooling of moisture that provides a nidus for infection and can cause excessive irrigation that removes the immunologic mucus blanket of the nose that serves as the body's natural defense from antigens and pathogens.
Systemic steroid dosing has its own risks, and injection therapy requires frequent visits to the physician to obtain adequate dosing. High volume nasal rinses have been shown to be ineffective for delivery of drugs. Metered dose inhalers do not deliver enough drug nor do they deliver the drug to the right location, with data showing that 90% of the material reaches only the antrum or front third of the nasal cavity.
Devices used for administering liquid medication to a patient by way of mist or liquid droplets are generally called nebulizers. Typical prior art nebulizers are designed with a single exist port whereby mist or liquid droplets exit the device to be inhaled by the patient. The mist from these nebulizers leaves the device in a low pressure flow rate as a result of baffles or air dams that redirect a venturi jet stream of liquid droplets as the liquid medication is drawn from a liquid reservoir in the device. These devices are best suited for the inhalation of the liquid droplets through the patient's mouth. However, medical conditions such as benign nasal neoplasms require the introduction of liquid droplets through the patient's nasal passages.
Current nebulizers, with a single orifice and typically low pressure flow rates, are not effective for introducing liquid medication through the two nostrils of a patient, particularly when the patient's nasal passages are congested or otherwise obstructed. In addition, current nebulizers are designed primarily to deliver particles to the lower airways and require considerable interaction from the patient, including long delivery times.
Therefore, it would be desirable to have a method for quickly delivering droplets or mists with an air stream and particle size designed to stay in the upper airway and reach the whole of the nasal mucosa for purposes of nasal irrigation and drug delivery.